Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants (par.) meeting eligibility criteria at screening entered a 7-day randomized, double-blind, placebo-controlled phase. At Day 8, all par. entered an open-label phase and continued to receive dolutegravir with an optimized background regimen. A total of 75 par. were screened; 45 par. were screen failures, and 30 par. were randomized.

Reporting Groups

Description

DTG 50 mg BID

Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase

Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Participant Flow for 2 periods

Period 1: Double-blind Phase

DTG 50 mg BID

Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase

STARTED

14

16

COMPLETED

14

16

NOT COMPLETED

0

0

Period 2: Open-label Phase

DTG 50 mg BID

Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase

STARTED

13
[1]

16

Ongoing

12

15

COMPLETED

0

0

NOT COMPLETED

13

16

Adverse Event

1

0

Lack of Efficacy

0

1

Ongoing

12

15

[1]

One participant completing the DB Phase withdrew on Day 8 and did not enter the Open-label Phase.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

DTG 50 mg BID

Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase

Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT]) [ Time Frame: From the day of the first dose of study drug until early withdrawal or the Day 8 analysis cut-off date (average of 14 study weeks) ]

Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks) ]

Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks) ]

Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks) ]

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days) ]

Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days) ]

Serious adverse events (SAEs) and non-serious AEs were collected in the time period from the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks).

Additional Description

SAEs and AEs were collected in members of Safety Population, comprised of all randomized participants who received at least one dose of study medication.

Reporting Groups

Description

DTG 50mg BID

Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase

Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.